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Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity

NCT00680979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2019-10-01

No results posted yet for this study

Summary

This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain.

Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures:

Visit 1

* Height and weight measurements.
* Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors.

Visit 2

* Physical examination, blood and urine tests.
* DXA scan to measure body fat, muscle and bone mineral content.
* Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms.
* Interview about the child s mood and psychological functioning.

Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.

Conditions

Interventions

BEHAVIORAL

Interpersonal Psychotherapy

BEHAVIORAL

Health Education

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Jack A Yanovski, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-15
Primary Completion
2015-04-16
Completion
2015-04-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680979 on ClinicalTrials.gov